Autoinjector with a signaling device

ABSTRACT

An autoinjector for dispensing a liquid product includes a housing; a product container arranged in the housing, particularly, a syringe comprising a displaceable piston; a drive member; a first spring which acts on the drive member and the piston to dispense the product from the container; signal element releasably axially coupled with the drive member so that the signal element is transported in the dispensing direction as said drive member is displaced; and a second spring, which exerts a spring force on the signal element against the dispensing direction and is tensioned as the signal element is transported in the dispensing direction. When the signal element is released or detached from the axial coupling, the second spring causes the signal element to accelerate opposite the dispensing direction and strike against a signal stop and generate an acoustic and/or tactile signal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of International Patent ApplicationNo. PCT/CH2014/000035 filed Mar. 20, 2014, which claims priority toEuropean Patent Application No. 13160614.7 filed Mar. 22, 2013 andEuropean Patent Application No. 13178676.6 filed Jul. 31, 2013, theentire contents of each are incorporated herein by reference.

TECHNICAL FIELD

The invention relates to an autoinjector, which is also often referredto as an autoinjection device, with which a product contained in aproduct container is automatically dispensed following a triggerrelease. The liquid product is, in particular, a medication. Theinvention particularly relates to a signaling device that generates anacoustic or tactile signal at the end of product dispensing in order toinform the user as to the end of the completed product dispension.

BACKGROUND

Autoinjectors are known in the art. Devices are also known which signalthe end of product dispension. An injection device is known from DE102008037310 A1 and WO 2010/017650 A1 which has a spring element on thepiston rod that, at the end of the automatic dispensing, radially snapsover ribs on the housing and produces the so-called “end click.”

Injection devices, in particular, autoinjectors are further known fromDE 10359694 A1 and WO 2004/047892 A1, having a needle protective sleevewhich is supported on a needle protective spring that is not tensed.During the automatic injection procedure with the needle, the needleprotective spring is tensed. After removal of the injection device fromthe injection site, the spring, which is now tensed, can now push theneedle protective sleeve over the needle tip in distal direction.

SUMMARY

An object of the invention is to provide an autoinjector having a devicefor generating an acoustic and/or tactile signal, with a low-cost andoperationally reliable design of the autoinjector.

The object is achieved with the autoinjector according to theindependent claims with advantageous further developments arising fromthe dependent claims, the description, and the figures.

The autoinjector according to the invention has a housing and a productcontainer arranged in the housing. The product container can be, inparticular, a syringe having a syringe body, on the distal end of whichan injection needle is fixedly arranged. The preferably cylindricalsyringe body surrounds a piston that is moveable relative to the syringebody and is pushed in the direction of the distal end for dispensing theproduct, whereby the liquid product, in particular, a medication, thatis located between the piston and the injection needle is dispensed fromthe product container through the injection needle. The syringe body maycomprise a flange, which may also be referred to as a finger flange, onits proximal end, e.g., end opposite the injection needle. A syringeformed in this way is available as a standard syringe, so that there isno specific requirement to develop a specially adapted syringe for theautoinjector. The piston is sealingly arranged against the insidediameter of the syringe body.

The housing is preferably elongated and forms the longitudinal axis ofthe autoinjector. The housing preferably has the shape of a sleeveand/or is cylindrical, in particular, circular cylindrical. The productcontainer is arranged in the housing. For example, the container can beslideably arranged in the housing, i.e., slideable in the distaldirection relative to the housing for automatic injection, so that theneedle tip protrudes from an opening on the distal end of theautoinjector and can be automatically injected into the patient.Optionally, with such a device the needle tip can be moved after productdispensing into the distal end of the device, in particular, the productcontainer can be moved in the proximal direction relative to thehousing.

In preferred embodiments, the product container is accommodated in thehousing so it cannot be moved along the longitudinal axis, inparticular, by means of a product container holder or a syringe holderthat holds the product in an axially fixed manner and is also connectedwith the housing in an axially fixed manner, in particular, in a lockingmanner. Preferably, the needle tip protrudes over the distal end of thehousing in the distal direction. In this way, the needle can be injectedinto the injection site by means of a movement of the housing toward thepatient. Preferably, a needle protective sleeve is provided that formsthe distal end of the autoinjector and has an opening for the injectionneedle that allows the needle to pass through the opening. The needleprotective sleeve can be arranged in its starting position relative tothe needle tip such that the needle protective sleeve distally protrudesover the needle tip or such that the needle tip protrudes distally overthe distal end of the needle protective sleeve. The needle protectivesleeve can be moved in the proximal direction relative to the housing byone activation stroke from its starting position into an actuatedposition, in particular, it can be moved into the housing so that theneedle protrudes, or further protrudes, from the distal end and/orthrough the opening of the needle protective sleeve. Preferably, theneedle protective sleeve can be moved in the distal direction relativeto the housing by one needle protective stroke from the actuatedposition into a needle protective position, in which the distal end ofthe needle protective sleeve protrudes distally over the needle tipafter the use of the device is completed and/or after the dispensing ofthe product is completed in order to prevent or reduce injury risksoriginating from an exposed needle tip. The needle protective sleevemay, for example, be displaced in the proximal direction, for example,against the force of a spring that may be referred to as the needleprotective spring, wherein the spring that is, for example, the secondspring described further below or a spring independent thereof, can movethe needle protective sleeve from the actuated position in the distaldirection, i.e., into the needle protective position. The autoinjectormay, for example, comprise an elastically arranged locking element thatlocks the needle protective sleeve in its needle protective position, inparticular, relative to the housing, and blocks a returning of theneedle protective sleeve in the proximal direction or into the housing.The locking element locks the needle protective sleeve at least in sucha manner that the needle cannot protrude from the distal end of theneedle protective sleeve. The needle protective sleeve may, for example,be moved from the needle protective position only to such an extent inthe proximal direction that the needle tip does not protrude from thedistal end of the needle protective sleeve.

The autoinjector further comprises a drive member that acts on thepiston, in particular, rests against the piston, at least during thedispensing of the product and a first spring which acts on the drivemember such as, for example, by supporting in particular, its distal endagainst the drive member. The drive member can, for example, besleeve-shaped and form a shoulder that is arranged, for example, in thearea of the distal end of the drive member against which the distal endof the first spring can be supported. The first spring is preferablyarranged within the sleeve-shaped drive member. The spring is preferablya coiled spring which acts as a compression spring and is preferablyformed of metal. The first spring is so highly pretensioned, inparticular, in the delivery state of the autoinjector, that it and/orthe energy stored therein is sufficient to essentially dispense theproduct completely out of the product container by the movement of thedrive member by one dispensing stroke. The movement of the drive memberby one dispensing stroke also moves the piston. If a space existsbetween the piston and the drive member in the delivery state, thedispensing stroke of the piston is smaller than the dispensing stroke ofthe drive member, which is preferable since the piston is unloaded untilused, thus preventing unwanted premature dispensing of the product. Inprinciple, however, it is also possible for the drive member to restagainst the piston in the delivery state and not only during thedispensing of the product. If the drive member rests against the pistonalready in the delivery state, the dispensing stroke of the pistoncorresponds to the dispensing stroke of the drive member. The proximalend of the first spring, which, due to its function, can also bereferred to as the dispensing spring, can be supported against thehousing or a stationary element within the housing, in particular, anelement that is only temporarily axially fixed relative to the housing.

According to the invention, the autoinjector comprises a signal element,a signal stop, and a second spring. The second spring may exert a springforce on the signal element in a direction opposite the dispensingdirection, or a spring force acting in the proximal direction. Inparticular, the second spring may be supported, for example, with itsproximal end, against the signal element.

The second spring may, for example, be a coiled spring acting as acompression spring that is supported with its proximal end against thesignal element. The spring can be supported, for example, with itsproximal end against the housing or against a stationary element withinthe housing. It is particularly preferred for the second spring to besupported with its distal end against the needle protective sleeve oragainst an element which is moveable together with the needle protectivesleeve during the movement of the needle protective sleeve relative tothe housing. For example, the element can be a switch module or a switchsleeve in the form described further below. The element can be arranged,in particular, kinematically and/or geometrically between the needleprotective sleeve and the distal end of the second spring. The advantagehereby is that the needle protective sleeve can be moved from itsactuated position into the needle protective position by means of thesecond spring. The spring can thus preferably fulfill a double functionsince it also exerts the aforementioned force on the signal element.

Especially in the delivery state or during a first partial stroke of thedispensing stroke of the drive member the signal element can be coupledin an axially fixed manner with the drive member so that the signalelement can be moved together with the drive member along thelongitudinal axis and in particular, relative to the housing inparticular, in the distal direction. The axially fixed coupling with thedrive member causes the signal element to be moved in the dispensingdirection during the movement of the drive member, in particular, whilethe first partial stroke of the dispensing stroke is being performed,and the second spring is tensed. During a second partial stroke of thedispensing stroke, it is preferable that the axially fixed couplingbetween the signal element and the drive member is released. The axiallyfixed coupling between the signal element and the drive member is thusreleasable. When the axially fixed coupling between the signal elementand drive member is released—and in particular, no other couplingsbetween the signal element and a further element are present, asdescribed further below—the signal element can be accelerated by meansof the second pretensioned spring in a direction opposite the dispensingdirection and relative to the drive member and/or the housing. As aresult of the signal element being moved together by the first partialstroke by the drive member, a space that extends, for example, along thelongitudinal axis, is formed between the signal stop and the signalelement that corresponds in particular, to the first partial stroke. Thesecond spring can accelerate the signal element across this space, andthereby the signal element strikes the signal stop at a speed such thatan impulse is imparted to the signal element that produces an acoustic(audible) and/or tactile (perceptible) signal.

The signal stop can be formed by the housing or an at least axiallyfixed element which is preferably non-rotatably connected to thehousing. For example, this element can be a closure cap on the proximalend of the housing and/or form the proximal end of the autoinjector.With particular preference, the closure cap can be connected in aform-locking manner or alternatively in a friction- or material-lockingmanner. Preferably, the element is locked together with the housing. Aseparate cap has the advantage that the assembly of the device isfacilitated with at least some of the components being arranged withinthe housing via the proximal end, which is subsequently closed with thecap. The cap may form a resonance body if the signal stop is arranged onthe cap so that by the design of material thicknesses and cap shapes theaudible impression of the acoustic signal can be changed within certainlimits.

In preferred embodiments, the signal element comprises a firstengagement element that is, in particular, elastically arranged and/oron an elastic arm and which detachably engages in a drive member, inparticular, in a recess of the drive member. In this way, the drivemember is coupled with the signal element in an axially fixed manner,with the axially fixed coupling between the drive member and the signalelement being released when the signal element, in particular, the firstengagement element, becomes disengaged or pushed out of engagement withthe drive member, in particular, out of the recess of the drive member.In particular, the first engagement element is released from engagementwith the drive member at the end of the first partial stroke of thedrive member.

Preferably, the signal stop is arranged along the longitudinal axis ofthe autoinjector such that it is in alignment with the signal element.This makes it possible for the signal element to strike the signal stopduring the movement of the autoinjector along the longitudinal axis.

In embodiments with a needle protective sleeve, it is preferable thatthe needle protective sleeve acts on the second spring, whereby fortriggering of the product dispensing the needle protective sleeve ismoveable from its starting position relative to the housing and alongthe longitudinal axis of the autoinjector in the proximal direction,i.e., in a direction opposite the dispensing direction, in particular,by the activation stroke. In this way, the second spring is tensed andpreferably the dispensing of the product, in particular, the movement ofthe drive member in the dispensing direction, is triggered. The needleprotective sleeve is thereby preferably moved from its starting positioninto its actuated position by the activation stroke so that its distalend is pressed against the injection site of the patient, whereby thehousing is being moved relative to the needle protective sleeve in thedirection of the injection site so the needle protective sleeve carriesout the activation stroke relative to the housing. The needle protrudingfrom the distal end of the needle protective sleeve is thereby alsoinjected into the injection site. After the completed dispensing of theproduct, especially after, for example, a short waiting period, e.g., 3to 10 seconds after the signal was generated by the signal element, theautoinjector is removed from the injection site whereby the needleprotective sleeve is moved from its actuated position into the needleprotective position relative to the housing by the needle protectivestroke, especially by means of the spring energy stored in the secondspring. The removal of the autoinjector from the injection site alsocauses the needle to retract from the injection site.

In certain embodiments, a switch module can be kinematically arrangedbetween the second spring and the needle protective sleeve, whereby theswitch module is transported in the proximal direction by the needleprotective sleeve when the needle protective sleeve is moved from itsstarting position into the proximal direction or into the actuatedposition and moves the needle protective sleeve in the distal directionwhen the spring acting on the switch module moves the switch module inthe distal direction. The switch module, or a part thereof, such as,e.g., a switch sleeve, can be an integral part of the needle protectivesleeve or, for example, be in form-locking connection, such as e.g.snapped on or resting loosely against the needle protective sleeve. Theswitch module may comprise a single part or several parts, wherein amultipart switch module can comprise at least the switch sleeve and ablocking sleeve. The blocking sleeve is moveable relative to the needleprotective sleeve and/or the switch sleeve, for example, along thelongitudinal axis. For example, the spring may be supported on theswitch sleeve and on the switch sleeve on the needle protective sleeve.It is possible to provide, for example, a unidirectionally actinglocking element between the blocking sleeve and the switch sleeve thatpreferably engages the aforementioned locking element, which locks theneedle protective sleeve in its needle protective position, that isformed, for example, by the blocking sleeve and engages in the switchsleeve, in particular, in a recess. The locking element is preferablydesigned such that during the movement of the switch sleeve relative tothe housing in the proximal direction, the switch sleeve moves theblocking sleeve via the locking element into a locking position, inparticular, during the movement of the needle protective sleeve from itsstarting position into an actuated position, and during the movementrelative to the housing in the proximal direction, the locking elementis moved into a blocking position relative to the blocking sleeve, inparticular, during the movement of the needle protective sleeve from itsactuated position into the needle protective position, whereby in theblocking position the locking element or another locking element, suchas, e.g., the one mentioned further above, blocks a movement of theswitch sleeve relative to the blocking sleeve in the proximal direction.This advantageously prevents the needle protective sleeve from beingpushed back into the housing from its needle protective position for arenewed release of the needle tip.

For example, the switch sleeve can comprise a first recess into whichthe locking element of the blocking sleeve detachably engages when theneedle protective sleeve is moved from its starting position into itsactuated position. The switch sleeve can comprise, for example, a secondrecess into which the locking element, or optionally the other lockingelement, engages when the needle protective sleeve is in its needleprotective position. The first and second recesses can be arranged at adistance relative to one another along the longitudinal axis thatpreferably corresponds to approximately the needle protective stroke. Ofcourse, a reversal of the arrangement of recesses and locking element orlocking elements is also possible, i.e., the at least one lockingelement can be formed on the switch sleeve and the at least one recess,i.e., the first recess and optionally the second recess can be formed onthe blocking sleeve.

The locking element and optionally the other locking element can beelastically arranged, in particular, each on an elastic arm. Preferably,the switch sleeve can surround and/or guide the blocking sleeve.

In preferred embodiments, the signal element can comprise a secondengagement element which is moveable by means of the disengagementmovement of the first engagement element with which the first engagementelement moves out of the drive element particularly into an axiallyfixed engagement with the needle protective sleeve or the switch module,in particular, with the blocking sleeve. The first engagement elementand the second engagement element are preferably coordinated with oneanother in such a way that the second engagement element alreadyengages, preferably in an axially fixed manner, in the needle protectivesleeve or the switch module when the first engagement element has notyet completely decoupled from engagement with the drive member. Thispreferably reliably prevents the first engagement element from beingreleased from engagement with the drive member when the secondengagement element has not yet engaged with the needle protective sleeveor the switch module. The needle protective sleeve or the switch module,in particular, the blocking sleeve can have, for example, an additionalrecess into which the second engagement element of the signal element isengaged, for example, for the axially fixed coupling between the signalelement and the signal module, in particular, the blocking sleeve or theneedle protective sleeve. The drive member can have a recess into whichthe first engagement element engages for the axially fixed couplingbetween the drive member and the signal element. Preferably, the firstengagement element and the second engagement element are formed on ashared elastic arm, wherein the first engagement element is directed,for example, radially in direction of the longitudinal axis, and thesecond engagement element is directed, for example, radially, in thedirection opposite the longitudinal axis. The first and secondengagement elements can be preferably located radially between the drivemember and the needle protective sleeve or the switch module, inparticular, between the blocking sleeve.

In particular, during the dispensing stroke of the drive member,especially at the end of the first partial stroke, the first engagementelement is released from engagement with the drive member and preferablyat the same time, the second engagement element becomes engaged with theswitch module or the needle protective sleeve, in particular, with amovement transverse to the longitudinal axis. In particular, by itsmovement into the dispensing direction, the drive member can press thefirst engagement element out of the recess of the drive member and thesecond engagement element into the recess of the needle protectivesleeve or the switch module, in particular, into the recess of theblocking sleeve.

In particularly preferred embodiments, the needle protective sleeve orthe switch module, in particular, the blocking sleeve, can hold thefirst engagement element in engagement with the recess of the drivemember, whereby the recess for the second engagement element is moved inthe direction of the second engagement element by the forward movementof the needle protective sleeve from its starting position to itsactuated position relative to the longitudinal axis, wherein the recessin the actuated position of the needle protective sleeve, in particular,at the moment the dispensing stroke is released, is arranged at adistance to the second engagement element along the longitudinal axisthat corresponds approximately to the first partial stroke of the signalelement. The drive member, released for the dispensing stroke by theactivation of the needle protective sleeve, can then be moved by thefirst partial stroke into the dispensing direction. Preferably, thefirst engagement element is held in engagement with the drive member bythe inner circumference of the needle protective sleeve or the switchmodule, in particular, the blocking sleeve against which the secondengagement element is resting. At the end of the first partial strokethe second engagement element is located in the same position relativeto the longitudinal axis as the recess allowing the second engagementelement to move into its recess and the first engagement element to moveout of its recess.

The dispensing stroke of the drive member can comprise, in particular,two phases, namely the first partial stroke and the second partialstroke. During the first partial stroke, the first engagement element isin axially fixed engagement with the drive member, and the secondengagement element out of the axially fixed engagement with the needleprotective sleeve or the switch module, in particular, the blockingsleeve. During the second partial stroke of the dispensing stroke, thesecond engagement element is in an axially fixed engagement with theneedle protective sleeve or the switch module, in particular, theblocking sleeve, wherein the first engagement element is out ofengagement with the drive member, advantageously causing the drivemember to be moveable by means of the first spring in the distaldirection relative to the signal element, and/or the signal element tonot yet be triggered for the emitting of the signal.

It is generally preferred that the drive element can be moved into thedistal direction relative to the signal element by means of the firstspring, in particular, by the second partial stroke, when the firstengagement element is out of engagement with the drive member and thesecond engagement element is in engagement with the needle protectivesleeve or the switch module.

In preferred embodiments, the second engagement element and the recessfor the second engagement element can be arranged in the delivery stateof the autoinjector along the longitudinal axis at approximately adistance relative to one another that corresponds to approximately thesum of the activation stroke of the needle protective sleeve and thefirst partial stroke of the drive member, which correspondsapproximately to the stroke of the signal element away from the signalstop.

Preferably, the drive member can prevent the second engagement elementfrom moving out of the axially fixed engagement in the needle protectivesleeve or the switch module when the drive member moves in the distaldirection relative to the signal element, in particular, during thesecond partial stroke of the drive member. At the end of the dispensingstroke and/or the second partial stroke, the drive member allows thesecond engagement element to move out of the engagement with the needleprotective sleeve or with the switch module. When at the end of thesecond partial stroke the second engagement element has moved out of itsengagement with the needle protective sleeve or the switch module, thesecond spring accelerates the signal element in a direction opposite thedispensing direction and the signal element strikes the signal stop.Preferably, the second engagement element is held in engagement with theneedle protective sleeve or the switch module by the outer circumferenceof the drive member against which the first engagement element isresting.

In preferred embodiments, the autoinjector may comprise a holdingelement against which, for example, an end of the first spring, inparticular, the proximal end of the first spring, is supported.Alternatively, the spring can be supported with its proximal end againstthe housing or on a stationary element within the housing. The holdingelement itself can be fixed to the housing or be moveably arrangedrelative to the housing. The holding element may comprise a firstengagement element that engages in the drive member prior to dispensingof the product, thereby preventing the drive member from moving in thedispensing direction relative to the holding element and/or the housing.The engagement of the first engagement element in the drive member isreleasable for the dispensing of the product. When the engagement isreleased, the drive member is released for movement in the dispensingdirection. The first spring can move the drive member relative to theholding element and/or the housing by one dispensing stroke in thedirection of dispensing. The drive member can have a recess for thefirst engagement element of the holding element, with this couplingbetween the drive member and the holding element being released when theholding element, in particular, the first engagement element, has movedout of engagement with the drive member, in particular, out of therecess of the drive element. In particular, the first engagement elementcan be released from engagement with the drive member by the needleprotective sleeve being moved by the activation stroke from its startingposition into the actuated position. For example, the first engagementelement can be held in an axially fixed engagement with the drive memberby the needle protective sleeve or the switch module, in particular, theblocking sleeve, when the needle protective sleeve is not in itsactuated position or in its starting position. For example, an innercircumference of the needle protective sleeve or the switch module, inparticular, of the blocking sleeve, can hold the first engagementelement in the engagement with the drive member, with, for example, asecond engagement element, which is described further below, restingagainst the inner circumference.

By the movement of the needle protective sleeve into its actuatedposition, the needle protective sleeve or the switch module, inparticular, the blocking sleeve, can allow the first engagement elementto move out of engagement with the drive member, in particular, with amovement transverse to the longitudinal axis of the autoinjector. Forexample, a recess, in particular, for the second engagement element,which is formed on the needle protective sleeve or the switch module,especially on the blocking sleeve, can be arranged relative to thelongitudinal axis in the same position as the first and/or the secondengagement element so that the first engagement element can move out ofengagement with the drive member. For example, the drive member canpress the first engagement element out of engagement with the drivemember when the needle protective sleeve is in its actuated position.

The first engagement element can, for example, be directed in a radialdirection relative to the longitudinal axis and/or be arranged on anelastic arm of the holding element.

As mentioned, the holding element can comprise a second engagementelement that by means of the disengagement movement of the firstengagement element out of the drive member is moveable into an axiallyfixed engagement with the needle protective sleeve or with the switchmodule, in particular, with the blocking sleeve. The second engagementelement can be arranged, for example, on the arm on which the firstengagement element is arranged and/or, for example, be directed in aradial direction away from the longitudinal axis. The first engagementelement and the second engagement element can be coordinated with oneanother such that the second engagement element already engages in anaxially fixed manner in its recess, which is formed by the needleprotective sleeve or the switch module, in particular, by the blockingsleeve, when the first engagement element is not yet completely releasedfrom the engagement with the drive member. This advantageously achievesthat the axially fixed connection between the holding element and theneedle protective sleeve or the switch module is established before theaxially fixed connection between the holding element and the drivemember is released, thus blocking a renewed or further pushing back ofthe needle protective sleeve.

Especially when the second engagement element is in its recess, thedrive member can move in the distal direction relative to the holdingelement, in particular, as a result of the energy stored in thepretensioned spring. The drive member can prevent the second engagementelement from moving out of the axially fixed engagement in the needleprotective sleeve or in the switch module, in particular, in theblocking sleeve, when the drive member moves in distal directionrelative to the signal element. Preferably, this applies at the end ofthe dispensing stroke, in particular, also when the second engagementelement of the signal element is released from its recess in order to beaccelerated by the second spring in a direction opposite the dispensingdirection.

Particularly, in embodiments in which the recess for the secondengagement element of the holding element is formed by the needleprotective sleeve or the switch sleeve, it is preferred that the secondengagement element moves out of its recess at the end of the dispensingstroke, so that the needle protective sleeve can be moved out of theactuated position into the needle protective position afteradministration of the product. For this purpose, the drive member canhave a recess into which the first engagement element can move, wherebythe second engagement element simultaneously moves out of its recess, inparticular, in order to release the movement of the needle protectivesleeve in the distal direction.

In embodiments comprising a switch module having a switch sleeve and ablocking sleeve it is preferable that the second engagement element alsoremains at the end of the dispensing stroke such that the secondengagement element prevents the blocking sleeve from being moved in thedistal direction relative to the housing and/or the second engagementelement, whereby the switch sleeve and/or the needle protective sleeveare slideable in the distal direction relative to the blocking sleeve,in particular, by means of the energy stored in the second spring,causing the needle protective sleeve to be moved, in particular, intoits needle protective position. As already described and noted only forthe sake of completeness, the locking element between the blockingsleeve and the switch sleeve can be brought into an engagement thatprevents the switch sleeve from being slideable in the proximaldirection relative to the blocking sleeve. Preferably, a movement of theblocking sleeve in the proximal direction is prevented by the blockingsleeve striking either against the housing or against a stationaryelement such as, for example, a mechanism holder within the housing, oragainst the signal element.

Another aspect of the invention relates to the design of a productcontainer, in particular, a tip holder for an autoinjector, inparticular, for an autoinjector in which the product container is notslideable relative to the housing and/or for an autoinjector of the typedescribed above.

The invention is based on a syringe module which is provided, inparticular, for use in an autoinjector. In particular, an autoinjectorhaving said syringe module can be provided. The syringe module comprisesa syringe and a syringe holder. The syringe comprises a syringe body, apiston, and a needle, with the needle being, for example, non-detachablysecured to a needle holding section of the syringe, and the piston beingslideably arranged in a cylindrical section of the syringe body, withthe syringe body having a tapering section or area arranged between theneedle holding section and the cylindrical section. The syringe furthercomprises a needle protective cap, which can be, for example, aso-called soft needle shield or, preferably, a rigid needle shield. Asoft needle shield is preferably constructed of rubber-elastic plastic,and a rigid needle shield is constructed of a rigid plastic sleeve inwhich a sleeve of a rubbery plastic is arranged. The sleeve made ofrubbery plastic and the rigid plastic sleeve together form the rigidneedle shield. The needle protective cap, which covers the needle and isfastened to the needle holding section, extending, in particular, to theneedle holding section extending conically in the direction of theneedle tip, preferably protects the needle from soiling and keeps itsterile. A gap is formed between the tapering section and the needleprotective cap, in particular, the rigid plastic sleeve.

The syringe holder comprises at least one engagement element, inparticular, a shoulder against which the tapering section of the syringeis supported in the distal direction and which engages in the gapbetween the needle protective cap and the tapering section.Advantageously, resting of the tapering section against the at least oneshoulder prevents the syringe from being able to move in the distaldirection relative to the syringe holder.

It is preferred for a gap to exist or form between the shoulder and theneedle protective cap so as to prevent force from being exerted on theneedle protective cap by the shoulder. This advantageously prevents thesterility of the needle from being compromised by an unintentionaldisplacement of the needle protective cap by the shoulder.

In preferred embodiments, the syringe body may comprise a finger flangeon its proximal end, whereby a gap is formed between the finger flangeand the syringe body when the tapering section rests against theshoulder, causing essentially no force to be exerted on the fingerflange. This advantageously prevents too much force from being exertedon the finger flange causing the syringe body to break.

It is further preferred for the syringe holder to comprise at least oneholding element, in particular, a projection directed outward with whichthe syringe holder can be connected or is connected with a housing ofthe autoinjector in an axially fixed manner, in particular, is snappedon or capable of being snapped on.

In particular, the syringe holder may comprise at least one cam, whichis elastically arranged, in particular, on an arm and is arranged, forexample, distal to the holding element. The at least one cam can inhibitor prevent a needle protective sleeve from moving from its startingposition into its actuated position such that when a limiting force isexceeded that is exerted on the needle protective sleeve along thelongitudinal axis L of the autoinjector, the at least one cam is pressedout of the engagement with the needle protective sleeve, enabling theneedle protective sleeve to be abruptly moveable into its actuatedposition relative to the housing.

The housing of the autoinjector can, for example, comprise a holdingsection that rests against the syringe holder, in particular, against anouter surface or an outer circumference of the syringe holder andprevents the at least one engagement element from moving transversely tothe longitudinal axis in a direction opposite the longitudinal axis. Inparticular, the holding section can be ring-shaped and surround the atleast one engagement element, preferably two or three or four engagementelements, so that the at least one engagement element is arranged withinthe holding section. During assembly and/or placement of the syringe inthe syringe holder, the syringe holder is not engaged with the holdingsection of the housing. When the syringe is placed completely in thesyringe holder, in particular, the at least one engagement elementengages in the gap between the tapering section and the needleprotective cap, the syringe module and/or the syringe holder is broughtinto engagement with the holding section, so that the at least oneengagement element is prevented from moving out of engagement with thetapering section transverse to the longitudinal axis, in particular, ina direction opposite the longitudinal axis or outward.

In a first variant, the at least one engagement element may be formedelastically, in particular, on one arm on the syringe holder, wherebythe syringe is pushed with its proximal end and with the needle facingforward into the syringe holder, which is preferably sleeve-shaped,whereby the needle protective cap deflects the at least one engagementelement outward transverse to the longitudinal axis, i.e., in adirection opposite the longitudinal axis, whereby, if the needleprotective cap was moved completely past the at least one engagementelement, the at least one engagement element snaps into the gap betweenthe tapering area and the needle protective cap. Subsequently, thesyringe holder with the syringe is moved into engagement with theholding section of the housing of the autoinjector, allowing the atleast one engagement element to be held in engagement with the gapbetween the needle protective cap and the tapering section and can nolonger spring out of this engagement. In another variant, the syringeholder can comprise at least two shell bodies, in particular, twohalf-shells, preferably each comprising such an engagement element. Theengagement element may be arranged rigidly, i.e., essentially immovablyon the shell body. By joining together the at least two shell bodies,the at least one engagement element can be inserted into the gap betweenthe needle protective cap and the tapering section of the syringearranged between the shell bodies, which blocks the syringe from movinginto the distal direction.

In particular, two shell bodies can be connected via a pivotable joint,allowing the shell bodies to be pivoted relative to one another from aninsertion position, in which the syringe can be placed in the syringecontainer, into a closing position in which the at least one engagementelement engages in the gap between the needle protective cap and thetapering area. The shell bodies can lock, or be locked, together in theclosing position, or alternatively rest loosely against each otherwhereby the shell bodies are held together by the holding section.

Since the shell bodies are preferably formed of plastic, such as e.g.transparent plastic, the pivoting joint can be a film hinge, so that thefirst and second shell bodies are integrally connected by the filmhinge.

Alternatively, the pivoting joint can be a hinge having at least onehinge pin and at least one hinge pin holder in which the hinge pin isarranged, in particular, is locked in place, and relative to which thehinge pin is pivotable and/or on along which the hinge pin slides duringpivoting. For example, the first shell body can comprise two hinge pinsand the second shell body can comprise two hinge pin holders for the twohinge pins. Preferably, the first shell body comprises one hinge pin andone hinge pin holder each, with the second shell body likewisecomprising one hinge pin and one hinge pin holder each and the hinge pinof the one shell body is inserted, or can be inserted, into the hingepin holder of the other shell body. The advantage hereby is that thefirst shell body and the second shell body can be formed in the same wayand can be quickly joined together, so that the tooling costs forproduction can be reduced.

The pivoting axis of the pivoting joint can be parallel or transverse,in particular, vertical or tilted relative to the longitudinal axis ofthe syringe, in particular, relative to the injection needle of thesyringe. If the pivoting axis is parallel to the longitudinal axis, itis preferable that the pivoting axis is arranged laterally relative tothe syringe body. If the pivoting axis is arranged transversely to thelongitudinal axis, it is preferred that the hinge and/or the pivotingaxis is arranged on the proximal end of the syringe holder.

In preferred embodiments, the first and second shell body can be joinedtogether by a linear movement transversely to the longitudinal axis, andthat at least one engagement element moved during joining into the gapsbetween the needle protective cap and the tapering area of the syringebody, in particular, by the linear joining movement. The first andsecond shell bodies can be locked or snapped in place on opposite sidesrelative to the syringe diameter; alternatively, they can loosely restagainst one another, whereby the holding section of the housing of theautoinjector can hold the shell bodies together.

Preferably, the first shell body and the second shell body are connectedin a joining position, in which the syringe can be placed in the syringebody, connected by means of at least one, preferably by a plurality ofpredetermined breaking points, whereby the at least one predeterminedbreaking point is broken by pressing together the first and the secondshell body against one another, which brings the first and second shellbodies into their locked position, in which the at least one engagementelement engages in the gap between the needle protective cap and thetapering area. Prior to breakage of the at least one predeterminedbreaking point, the first and the second shell body can be integrallyjoined together, whereby a sleeve-shaped body is formed into which thesyringe can be inserted through the proximal end of the body, inparticular, with the needle or the needle protective cap facing forward.

It is generally preferred that the first shell body and the second shellbody comprise the at least one projection for the connection with thehousing and/or the cam to provide resistance when the needle protectivesleeve is pushed back.

In further embodiments, the first shell body can comprise the at leastone engagement element whereby a lateral opening through which thesyringe can be inserted laterally into the first shell body, and withlateral insertion of the syringe into the syringe body the at least oneengagement element is inserted into the gap between the needleprotective cap and the tapering section. For example, the first shellbody can comprise the at least one projection and/or the at least onecam.

Preferably, the syringe holder comprises a second, in particular,sleeve-shaped shell body into which the first shell body can be insertedtogether with the syringe and with a movement along the longitudinalaxis, in particular, through the proximal end of the second shell bodyand preferably with the needle tip or the needle protective cap facingforward. In the embodiment with the second shell body, the second shellbody can optionally comprise the at least one projection and/or the atleast one cam.

Preferably, the second shell body can comprise a translation motionstop, against which rests a translation motion counter-stop of the firstshell body, so that a displacement of the first shell body housed in thesecond shell body is prevented in the distal direction relative to thesecond shell body, i.e., in particular, when the first shell body isinserted into the second shell body. The holding section of the housingcan be preferably designed in such a way that the at least oneengagement element of the first shell body is held in engagement withthe tapering area and preferably also rests against the area of thesecond shell body in which the translation motion stop is formed.

In further preferred embodiments, the syringe holder can comprise atleast one first sleeve-shaped shell body, in particular, a sleeve-shapedbasic body and at least one, preferably two, pivoting levers, with thepivoting lever being pivotably arranged about a pivoting axis on thefirst shell body by means of a hinge. The pivoting axis can preferablyextend transversely to the longitudinal direction of the syringe,preferably on a skewed line relative to the longitudinal axis of thesyringe. The engagement element can be arranged on the pivoting lever,and with several pivoting levers preferably on each of the severalpivoting levers, in particular, the end of the pivoting lever oppositethe pivotal axis. Preferably, the engagement element is arranged at aposition distal to the pivoting joint. The pivoting joint can be a filmhinge which connects the pivoting lever and the first sleeve-shapedshell body. Alternatively, the pivoting joint can be a hinge having atleast one hinge pin and at least one hinge pin holder in which the hingepin is arranged, preferably locked in place, and relative to which thehinge pin is pivotable and/or along which the hinge pin slides duringpivoting. Preferably, the pivoting lever can comprise two hinge pins andthe sleeve body can comprise two hinge pin holders for the hinge pins ofthe pivoting lever, or vice-versa. When several pivoting levers arepresent, several such pivoting pin holders can accordingly be present.

Preferably, the holding section of the housing can act in such a manneron the at least one pivoting lever, in particular, be resting againstthe at least one pivoting lever, such that the engagement element isheld in engagement with the tapering area of the syringe body. When thesyringe is inserted via the proximal end of the sleeve body with theneedle and/or in particular, the needle protective cap facing forward,the at least one engagement element is pivoted outward, causing theneedle protective cap to be moved past the at least one engagementelement, so that the at least one engagement element can engage in thegap if the gap is in the position of the at least one engagement elementrelative to the longitudinal axis.

Preferably, the cam for the needle protective sleeve can be formed onthe pivoting lever. In particular, the pivoting lever can be a two-armpivoting lever, whereby the cam is formed on one arm that preferablyprotrudes in the proximal direction from the pivoting joint, and whereon the other arm that preferably protrudes in the distal direction fromthe pivoting joint, the at least one engagement element is formed. Whenthe holding section of the housing holds the pivoting lever inengagement with the tapering area, the pivoting arm on which the cam isarranged can be elastically deformed when the needle protective sleeveis pushed back.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded representation of an autoinjector according to anespecially preferred embodiment.

FIGS. 2 a-2 c are the autoinjector of FIG. 1 in a delivery state, inwhich FIGS. 2 a to 2 c are sectional views across the longitudinal axisof the device, whereby the sectional views are at different angles aboutthe longitudinal axis.

FIGS. 3 a-3 c are the device and the views from FIGS. 2 a-2 c, whereby aneedle protective sleeve is in its actuated position.

FIGS. 4 a-4 c are the device and the views from FIGS. 2 a-2 c, wherebythe drive member is shown at the end of a first partial stroke of itsdispensing stroke.

FIGS. 5 a-5 c are the device and the views from FIGS. 2 a-2 c, whereby adrive member is shown at the end of its dispensing stroke.

FIGS. 6 a-6 c are the device and the views from FIGS. 2 a-2 c, whereby asignal which signals the end of the dispensing of the product isgenerated.

FIGS. 7 a-7 c are the device and the views from FIGS. 2 a-2 c, wherebythe needle protective sleeve is in its needle protective position.

FIGS. 8 a-8 d are perspective views of a multipart syringe holderaccording to a first variant.

FIGS. 9 a-9 c are perspective views of a syringe holder according to asecond variant.

FIGS. 10 a-10 d are perspective views of a syringe holder according to athird variant.

FIGS. 11 a-11 c are perspective views of a syringe holder according to afourth variant.

FIGS. 12 a-12 c are perspective views of a syringe holder according to afifth variant.

FIGS. 8 e, 9 d, 10 e, 11 d, and 12 d are longitudinal sections of thefive embodiments in the delivery state and for the embodiments two tofive, in a position with a partially and a completely inserted syringe,respectively.

DETAILED DESCRIPTION

With reference to FIGS. 1-7 c, the structural features and the functionof the preferred autoinjector will now be described.

The autoinjector comprises a sleeve-shaped, longitudinal housing 2 witha longitudinal axis L, having a locking cap 12 on its proximal end,which is form-fittingly connected with the housing 2 for conjoint andaxial rotation and forms the proximal end of the autoinjector. Thelocking cap 12 is snapped on the housing 2. To this end, the locking cap12 comprises a locking element 12 a, which is locked into a recess 2 aon the housing 2, preferably in such a manner that the locking cap 12cannot, or cannot be readily decoupled from the housing 2.

A pull cap 4 is arranged on the distal end of the autoinjector in itsdelivery state (FIGS. 2 a-2 c) that it is pulled off, or rotated off,and removed before the autoinjector is used.

A product container 13 in the form of a syringe is non-slidablyaccommodated in the housing 2—except when the autoinjector isassembled—along the longitudinal axis L relative to the housing 2. Theproduct container 13 comprises a sleeve-shaped syringe body surroundinga piston 13 b which sealingly rests against the inner circumference ofthe syringe body. On its distal end, the syringe body comprises aninjection needle 13 a that is, in particular, nondetachably connected tothe syringe body, the distal end of which is formed by the needle tip. Aliquid product, in particular, a medication, is located within thesyringe body between the injection needle 13 a and the piston 13 b,whereby the liquid product is dispensed through the hollow injectionneedle 13 a from the product container 13 by movement of the piston 13 bin a dispensing direction, i.e., in the distal direction or toward theinjection needle 13 a. The syringe body comprises a so-called fingerflange on its proximal end that projects radially outward beyond theouter circumference of the cylindrical syringe body.

The product container 13 is accommodated in a product container holder,which is referred to as a syringe holder 1, in such a way that it issecured against a movement at least along the longitudinal axis L indistal direction relative to the syringe holder 1. As can best be seenin FIG. 2 a, the syringe holder 1 is connected with the housing 2 in aform-locking manner, in particular, it is locked in place. To this end,the housing 2 comprises recesses into which locking elements engage,which are formed on the proximal end of the syringe holder 1. Thesyringe holder 1 comprises at least one inward projected shoulder 1 b,on which a tapering section of the product container 13 is supportedwhich is distal to the cylindrical syringe body section that guides thepiston 13 b.

In order to prevent that the product container 13 is slideable in theproximal direction relative to the syringe holder 1, the proximal end ofthe product container 13 is pressed into engagement with the shoulder 1b by a holder acting on the syringe body. The holder is formed by aholder spring section 5 c of a mechanism holder 5. The mechanism holder5 is arranged in particular, non-slideable and/or for conjoint rotationrelative to the housing 2 along the longitudinal axis L. Thesleeve-shaped mechanism holder 5 can be snapped on the housing 2. Bymeans of the holding spring section 5 c, longitudinal differences of theproduct holder 13, which may arise as a result of manufacturingtolerances, can be compensated for, ensuring a fixed fitting of theproduct holder 13 on the shoulder 1 b.

The product container 13 is arranged relative to the housing 2 such thatthe needle tip projects distally beyond the distal end of the housing 2.In the starting- or delivering position of the autoinjector, i.e., whenthe pull cap 4 is arranged on the autoinjector, the needle 13 a iscovered by a needle cover cap 14, which is designed in the example shownas a so-called rigid needle shield known to experts, or alternatively,as a soft needle shield in order to protect the needle 13 a from soilingand/or to keep the needle 13 a and the medication sterile. The rigidneedle shield 14 is arranged on a needle holding section of the syringebody, whereby the tapering section of the syringe body is locatedbetween the needle holding section and the cylindrical section of thesyringe body. The shoulder 1 b is arranged between the syringe body andthe proximal end of the rigid needle shield 14, in particular, such thatbetween the rigid needle shield 14 and the shoulder 1 b, a gap—whilesmaller—is formed in order to prevent the shoulder 1 b from exerting aforce on the rigid needle shield 14, that could, for example, compromisethe sterility of the needle 13 a or of the liquid product. The pull cap4 is removably latched into the housing 2 or into a needle protectivesleeve 3, whereby said latch is released when the pull cap 4 is removedfrom the housing 2 or the needle protective sleeve 3. The latch isformed in the example shown by a latch configuration 3 b of the needleprotective sleeve 3 and latch hook 4 a of the pull cap 4 (FIG. 2 b).These latch hooks 4 a further secure the pull cap 4 against a proximalmovement relative to the housing 2 by being fixedly supported on thehousing 2 or on a distal front side on the syringe holder 1. The pullcap 4 also comprises in particular, a latch hook 4 a with at least onesnap 4 b which engages in a gap between the syringe body, in particular,in its tapering area, and the proximal end of the rigid needle shield14. When the pull cap 4 is removed from the autoinjector, the snap 4 blatches into the proximal end of the rigid needle shield 14, whereby therigid needle shield 14 becomes detached from the product holder 13 andis removed together with the cover cap 4 from the autoinjector.

The autoinjector comprises a needle protective sleeve 3 which can bedisplaced relative to the housing 2 and along the longitudinal axis L byan activation stroke H_(B) in the proximal direction into an actuatedposition in order to trigger the dispensing of the product. In thestarting position of the needle protective sleeve 3, as it is shown inFIGS. 2 a-2 c, where the pull cap 4 is removed, the distal end of theneedle protective sleeve 3 protrudes distally over the needle tip of theneedle 13 a, so that access to the needle tip is initially prevented. Bydisplacing the needle protective sleeve 3 by the activation strokeH_(B), the needle protective sleeve 3 is moved in such a distance inproximal direction so that the needle 13 a projects from the distal endof the needle protective sleeve 3, in particular, with a lengthcorresponding to the injection depth of the needle into the injectionsite. Preferably, the needle 13 a should project beyond the distal endof the needle protective sleeve 3 to such an extent that a subcutaneousinjection can be carried out. In particular, the housing 2 can form astop 2 c against which the needle protective sleeve 3 comes to rest whenit is in the actuated position.

After the completed injection, the needle protective sleeve 3 can bemoved relative to the housing 2 along the longitudinal axis L by aneedle protective stroke H_(N) in the distal direction from the actuatedposition and into a needle protective position (FIGS. 7 a-7 c). In theneedle protective position, the distal end of the needle protectivesleeve 3 projects distally beyond the needle tip, so that access to theneedle tip is prevented and risk of injury risk is reduced. As describerfurther below, the needle protective sleeve 3 can be blocked against arenewed pushing back from the needle protective position.

The syringe holder 1 has a projection 1 a pointing radially outwardwhereby the projection 1 a engages in a slit-shaped recess of the needleprotective sleeve 3 located between the housing 2 and the syringe holder1. In the starting position of the needle protective sleeve 3 (FIGS. 2a-2 c) and/or in the needle protective position of the needle protectivesleeve 3 (FIGS. 7 a-7 c), the needle protective sleeve 3, in particular,the proximal end of the slit-shaped recess, rests against the projection1 a thereby preventing movement of the needle protective sleeve 3 in thedistal direction. Into this slit-shaped recess, alternatively intoanother recess of the needle protective sleeve 3, a cam 1 c which iselastically arranged on the syringe holder 1 and formed by the syringeholder 1 may engage. The cam 1 c is designed in such a way that with anattempt at moving the needle protective sleeve 3 from the startingposition into the actuated position, the cam 1 c initially prevents themovement of the needle protective sleeve 3, whereby the cam 1 c ispressed out when the force applied to the needle protective sleeve 3 forpushing back exceeds a certain threshold value, causing the needleprotective sleeve 3 to be abruptly pushed back into the actuatedposition. In this way, the needle 13 a can be abruptly inserted into theinjection site. For inserting the needle 13 a and/or for displacing theneedle protective sleeve 3 into the actuated position, the distal end ofthe needle protective sleeve 3 is placed on the injection site, wherebythe housing 2 is then pressed in the direction of the injection site; ifthe pressing force exceeds the aforementioned threshold value, thehousing 2 is abruptly moved toward the puncture site and the needleprotective sleeve 3 into the actuated position relative to the housing2.

The housing 2 comprises a ring-shaped holding section or a ring section2 b which, in particular, circularly surrounds the distal end of thesyringe holder 1 and rests against it, causing the at least one shoulder1 b to be held in engagement with the tapering area of the syringe body.The housing 2 further comprises a translation motion stop in form of aholding shoulder 2 e in the area of the holding section 2 b thatprevents the syringe holder 1 from being slideable in the distaldirection relative to the housing 2 when the syringe holder 1 restsagainst the holding shoulder 2 e. This also advantageously applies forthe variants described.

The autoinjector also comprises a sleeve-shaped drive member 7 whichforms a shoulder projecting inward on its distal end, on which a firstspring 9 is supported, which can also be referred to as dispensingspring. The first spring 9 is arranged within the sleeve-shaped drivemember 7. The first spring 9 is a coiled spring acting as a compressionspring, which is pretensioned in the starting- or delivery position ofthe autoinjector with so much energy that it can dispense the productcontained in the product container 13, in particular, completely out ofthe product container 13 by movement of the drive member 7 by onedispensing stroke H_(A). In the delivery state of the device, there is aspace between the piston 13 b and the distal end of the drive member 7,so that the drive member 7 strikes the piston 13 b and transports italong in the dispensing direction only while the dispensing stroke H_(A)is being executed.

The first spring 9 is supported with its proximal end on a holdingelement 6 comprising in this example two arms 6 c, whereby on each arm 6c a first engagement element 6 a and a second engagement element 6 b isarranged. The first engagement element 6 a points radially toward thelongitudinal axis L, and the second engagement element 6 b pointsradially away from the longitudinal axis L. The first engagement element6 a engages in a first recess 7 a which is formed by the drive element 7thereby preventing the movement of the drive member 7 in the distaldirection or in the dispensing direction relative to the holding element6. In this way, the first spring 9 is held in its tensioned state. Theholding element 6 comprises a guide pin 6 d which is inserted throughthe proximal end of the first spring 9 into the core of spring 9. Theguide pin 6 d prevents lateral outward bending of the first springduring and at the end of the dispensing stroke H_(A) of the drive member7.

The autoinjector comprises a switch module 8, 15 having a switch sleeve15 and a blocking sleeve 8 surrounded by the switch sleeve 15. In thedelivery state of the device, the first engagement element 6 a is heldin the engagement with the first recess 7 a by the inner circumferenceof the blocking sleeve 8 that rests against the second engagementelement 6 b.

The switch sleeve 15 is connected with the proximal end 3 a of theneedle protective sleeve 3 or at least rests against the proximal end 3a of the needle protective sleeve 3. A second spring 10 within which thefirst spring 9 is located and which preferably at least partiallysurrounds the switch sleeve 15 and the blocking sleeve 8 is supportedwith its distal end on the switch sleeve 15. A part of the switch sleeve15 is thus situated between the needle protective sleeve 3 and thedistal end of the second spring 10. The second spring 10 is a metalspring acting as a compression spring and designed as a coiled spring.The proximal end of the second spring 10 is supported on a signalelement 11, in particular, on a projection 11 c that is axiallydisplaceable and engages or conjoins with the housing 2 and whichreaches through a slit-shaped groove 5 b of the mechanism holder 5. Thesecond spring 10 thus also surrounds the mechanism holder 5 at leastpartially, preferably completely.

The switch element 15 comprises a recess 15 a in which a locking element8 a of the blocking sleeve 8 engages. The locking element 8 a issawtooth-shaped and protrudes radially away from the longitudinal axisL. The locking element 8 a is elastically arranged on one arm formed bythe blocking sleeve 8. By movement of the switch sleeve 15 in proximaldirection, the blocking sleeve 8 is transported in proximal directionvia the engagement of the locking element 8 a.

By movement of the needle protective sleeve 3 into the actuatedposition, the switch sleeve 15 is likewise transported by the activationstroke H_(B), whereby the second spring 10 is tensioned. If the needleprotective sleeve 3 is not completely moved into the actuated position,the second spring 10 can move the switch sleeve 15 and the needleprotective sleeve 3 back into the starting position, whereby theblocking sleeve 8 is also transported by the switch sleeve 15 viaengagement with the locking element 8 a.

In the delivery state or, prior to triggering of product dispensing, thesleeve-shaped signal element 11 is in an axially fixed engagement withthe drive member 7. The signal element 11 comprises a first engagementelement 11 a, which engages in a recess 7 b of the drive member 7, and asecond engagement element 11 b. The first engagement element 11 a andthe second engagement element 11 b are elastically arranged on the endof one arm 11 d. The signal element 11 comprises two such arms 11 d witha first engagement element 11 a and a second engagement element 11 b.The first engagement element 11 a points radially toward thelongitudinal axis L and the second engagement element 11 b pointsradially away from the longitudinal axis L. In the delivery state, thefirst engagement element 11 a is held by the inner circumference of theblocking sleeve 8 in axially fixed engagement with the drive member 7.The second engagement element 11 b rests against the inner circumferenceof the blocking sleeve 8. The locking cap 12 comprises a signal stop 12b, against which the signal element 11 can strike to generate a signaland preferably rests against the signal element 11 in the delivery stateof the device.

To administer the product from the product container 13, the pull cap 4is removed from the autoinjector together with the rigid needle shield14. The distal end of the needle protective sleeve 3 is placed on theinjection site of a patient, whereby the housing 2 is displaced towardthe injection site, causing the needle protective sleeve 3 to be movedby the activation stroke H_(B) from its starting position into theactuated position in the proximal direction relative to the housing 2.In this way, the second spring 10 is tensioned, whereby the switchsleeve 15 is transported along by the needle protective sleeve 3 by theactivation stroke H_(B). The blocking sleeve 8 comprises a first recess8 b which, as shown in FIGS. 3 a-3 c, is brought to the position of thesecond engagement element 6 b of the holding element 6 by movement ofthe blocking sleeve 8 by the activation stroke H_(B) along thelongitudinal axis L. In this way, the first engagement element 6 a ismoved out of engagement with the drive member 7 with a movementtransverse to and away from the longitudinal axis L, wherebysimultaneously the second engagement element 6 b is moved intoengagement with the blocking sleeve 8, especially with its first recess8 b. This releases the drive member 7 for movement in the dispensingdirection by the dispensing stroke H_(A).

Since the axially fixed coupling between the drive member 7 and theholding element 6 is now released, the holding element 6, which ismoveable by least some distance relative to the housing 2 and along thelongitudinal axis L, can be moved by the first spring 9 in the proximaldirection, whereby the holding element 6 transports the blocking sleeve8 by a start signal stroke H_(K) (FIG. 3 c) via engagement of the secondengagement element 6 b in the recess 8 b, causing the blocking sleeve 8to strike against a start signal stop 5 a, which is formed by themechanism holder 5, and thereby emits an acoustic and/or tactile signalwhich signals the user of the device that dispensing of the product hasstarted. The movement of the blocking sleeve 8 by the activation strokeH_(B), releases the locking element 8 a for a movement transversely toand toward the longitudinal axis L, since the mechanism holder 5comprises an indentation 5 d which allows such movement of the lockingelement 8 a when the blocking sleeve 8 was moved by the activationH_(B), or when the needle protective sleeve 3 is in its actuatedposition.

Since the signal element 11 is still axially fixedly connected with thedrive member 7, it is transported in the dispensing direction by a firstpartial stroke H_(S) of the dispensing stroke H_(A), whereby the signalelement 11 is moved by approximately the first partial stroke H_(S) awayfrom the signal stop, as can best be seen in FIG. 4 c. At the end of thefirst partial stroke H_(S), during which the first and second engagementelements 11 a, 11 b are moved relative to the blocking sleeve 8, thefirst engagement element 11 a is pressed out of its engagement with thedrive member 7, whereby the second engagement element 11 b issimultaneously moved into the second recess 8 c of the blocking sleeve 8in a movement transverse to the longitudinal axis L and radially awayfrom the longitudinal axis L. This prevents the signal element 11 frommoving in the proximal direction relative to the housing 2 or theblocking sleeve 8. The second engagement element 11 b is held by theouter circumference of the drive member 7 in engagement with the recess8 c (FIG. 4 a), when the drive member 7 is moved by its second partialstroke of the dispensing stroke H_(A). The outer circumferential surfaceof the drive member 7 holds the second engagement element 6 b inengagement with the first recess 8 b of the blocking sleeve 8, as canbest be seen in FIG. 4 b. At the end of the dispensing stroke H_(A), thedrive member 7 releases the second engagement element 11 b fromengagement with the blocking sleeve 8, causing the second engagementelement 11 b to be moved out of engagement with the recess 8 c, inparticular, toward the longitudinal axis L, so that the second spring 10accelerates the signal element 11 against the dispensing direction, i.e.in the proximal direction, so that when the signal element 11 strikesthe signal stop 12 b, an acoustic and/or tactile signal is generated.

As can best be seen in FIG. 5 b, the engagement of the second engagementelement 6 b in the first recess 8 b remains, which prevents a movementof the blocking sleeve 8 in the distal direction relative to the housing2.

By removing the autoinjector from the injection site, the second spring10 can move the switch sleeve 15 and the needle protective sleeve 3 fromthe actuated position into the needle protective position by the needleprotective stroke H_(N), whereby the locking element 8 a is pressed outof the engagement with the recess 15 a, and the switch sleeve 15 ismoved in the distal direction relative to the blocking sleeve 8. If theneedle protective sleeve 3 is in its needle protective position, thelocking element 8 a snaps on the switch sleeve 15, whereby the lockingelement 8 a prevents the needle protective sleeve 3 from being pushedback into its actuated position. In the attempt to push back the needleprotective sleeve 3 from the needle protective position into theactuated position, the switch element 15 strikes the locking element 8a, which prevents the movement of the needle protective sleeve 3 intothe actuated position. To this end, the blocking sleeve 8 is supportedaxially on the start signal stop 5 a of the mechanism holder 5.

Various embodiments of a syringe holder are shown in the following thatcan be used with an autoinjector, preferably, however, not necessarilyan autoinjector of the type described above.

The syringe module of FIGS. 8 a to 8 d comprises a first shell body orsleeve body 103 which has a lateral opening and at least one, i.e., inthe example shown, two shoulder-shaped engagement elements 1 b, whichproject inwards, i.e., toward the longitudinal axis of the sleeve body103.

The sleeve body 103 further comprises a translation motion counter-stop1 k pointing in the distal direction. For the assembling of the syringe13 (FIG. 8 b), it is inserted laterally into the sleeve body 103, i.e.,with a movement transverse to the longitudinal axis, whereby the atleast one engagement element 1 b is inserted into the gap between theneedle protective cap 14 and the tapering section of the syringe body ofthe syringe 13.

The syringe module further comprises a second shell body, in particular,sleeve body 104 (FIG. 8 c) that is open on its proximal end and on itsdistal end comprises at least one, i.e., in the example shown twotranslation motion stops 1 m projecting radially inwards. Like thesyringe holder 1 in the embodiment in FIGS. 1 to 7 c, the sleeve body104 comprises at least one cam 1 c, namely two cams 1 c and at least oneprojection 1 a, namely two projections 1 a. The cam 1 c is arrangedelastically on the sleeve body 104 via an arm.

The unit consisting of the syringe 13, the needle protective cap 14, andthe first sleeve body 103 is inserted into the second sleeve body 104(FIG. 8 c) via the proximal end along the longitudinal axis with theneedle protective cap 14 pointing forward (FIG. 8 b), whereby thetranslation motion counter-stop 1 k strikes the translation motion stop1 m, when the unit 13, 14, 103 has been completely inserted into thesleeve body 104 (FIG. 8 d). The unit shown in FIG. 8 d is then moved inthe housing 2 of the autoinjector in such a way during assembly that theholding section 2 b, in particular, the circular holding section or ringsection rests against the at least first sleeve body 103, at leastagainst the area of the engagement element 1 b, so that the engagementelement 1 b is held in engagement with the tapering section of thesyringe body. The holding section 2 b can further also rest against thesecond sleeve body 104, in particular, in the area on which the at leastone translation motion stop 1 m is formed, in order to keep thetranslation motion stop 1 m in engagement with the translation motioncounter-stop 1 k.

In the embodiment shown in FIGS. 9 a-9 c, the syringe module, inparticular, the syringe holder 1, comprises a first shell body 101 and asecond shell body 102, each formed as half-shells.

Each shell body 101, 102 comprises a cam 1 c and a projection 1 a in themanner described herein.

In the view shown in FIG. 9 a, the first shell body 101 and the secondshell body 102 are integrally connected with one another via severalpredetermined breaking points, whereby the first and second shell body101, 102 assume an insertion position relative to one another. Thesyringe 13 is inserted in the distal direction with the needleprotective cap 14 pointing forward (FIG. 9 b) through the proximal endof the bodies 101, 102, shown in FIG. 9 a, until the gap between thetapering section and the needle protective cap 14 along the longitudinalaxis L is in the same position as the at least one engagement element 1b. In the example shown, each of the first and second shell body 101,102 comprises an engagement element 1 b. By pressing the first andsecond shell body 101, 102 against one another transverse to thelongitudinal axis L the predetermined breaking points are broken,causing the first and second shell body 101, 102 to lock together in aform-locking manner, and the engagement elements 1 b to move into thegap. As already described, the areas of the first and second shell body101, 102, on which the engagement element 1 b is formed, can besurrounded by the holding section 2 b of the housing 2, whereby theengagement elements 1 b are held in the engagement with the taperingarea of the syringe body. With particular preference, during theinsertion of the syringe 13 transverse to the longitudinal axis, theshell bodies 101, 102 can move into the insertion position against theelastic force of the arms which carry the projection 1 a and/or the cam1 c. As described, here too the engagement elements 1 b can likewise besubsequently brought and held in engagement by the holding section 2 bof the housing 2 with the tapering section of the syringe body 13.Alternatively or additionally, the first shell body 101 and the secondshell body 102 can be locked together in the closing position (FIG. 9 c)in which the engagement elements 1 b engage in the gap.

In the embodiment shown in FIGS. 10 a-10 d, the syringe holder 1comprises a first shell body 101 and a second shell body 102, eachformed as a half-shell and, in particular, are of an identical design,so that tooling costs can be reduced.

Each first and second shell body 101, 102 comprises a cam 1 c and aprojection 1 a in the manner described. Further, each of the first andsecond shell body 101, 102 comprises an engagement element 1 b on itsdistal end.

Each of the shell body 101, 102 comprises a hinge pin 1 e and a hingepin holder 1 f (FIG. 10 a), wherein the hinge pin 1 e of the one shellbody 101, 102 is inserted into the hinge pin holder 1 f of the othershell body 102, 101 (FIG. 10 b), so that the first and second half-shell101, 102 can pivot relative to one another about the pivoting axis ofthe pivoting joint 1 e, 1 f, which is formed by the hinge pin 1 e andthe hinge pin holder 1 f, namely between an insertion position (FIG. 10c) and a closing position (FIG. 10 d). The syringe 13 is insertedtogether with the needle protective cap 14 through the proximal end ofthe syringe body 1, with the needle protective cap 14 being moved pastthe engagement element 1 b, whereby the first shell body 101 and thesecond shell body 102 are pivoted relative to one another when the gapbetween the needle protective cap 14 and the tapering area of thesyringe body is in the same position as the engagement elements 1 brelative to the longitudinal axis L. This causes the engagement elements1 b to engage in the aforementioned gap. As described, the engagementelements 1 b can be held in engagement with the tapering section of thesyringe body by the holding section 2 b of the housing 2. Alternatively,or additionally, the first shell body 101 and the second shell body 102can lock together in the closing position (FIG. 10 d) in which theengagement elements 1 b engage in the gap.

FIGS. 11 a to 11 c show an embodiment of the syringe holder 1 which hasa first sleeve body 103 and two pivoting arms 1 h. The projection 1 a isformed on the sleeve body 103. The sleeve body 103 forms two hinge pinholders 1 g for each of the pivoting arms 1 h, in which one hinge pin 1i of the pivoting lever 1 h is each arranged. Each of the pivotinglevers 1 h forms two hinge pins 1 i which are locked together with thehinge pin holder. The pivoting pin 1 i can be rotated relative to thepivoting pin holder 1 g and can slide along the hinge pin holder 1 g.The pivoting lever 1 h comprises a lever section pointing in distaldirection, whereby on the distal end of this lever section theengagement element 1 b formed by the pivoting lever 1 h, is formed forengagement in the gap between the needle protective cap 14 and thetapering section of the syringe body.

The pivoting lever 1 h shown in the example has two arms, whereby thelever section protruding from the pivoting joint 1 g, 1 i in theopposite direction as the arm that forms the engagement element 1 b,forms the cam 1 c.

The syringe 13 is introduced with the needle protective cap 14 pointingforward through the proximal end of the sleeve body 103 into the sleevebody 103 with the needle protective cap 14 being moved past theengagement elements 1 b until the gap between the tapering area of thesyringe body and the needle cap 14 is in the same position relative tothe longitudinal axis as the engagement elements 1 b. By pivoting thepivoting lever 1 h, the engagement elements 1 b are pivoted into the gapand/or toward the longitudinal axis. The unit shown in FIG. 11 c is thenarranged in the housing 2 of the autoinjector in such a way that theholding section 2 b fixes the pivoting lever 1 h such that theengagement elements 1 b are held in engagement with the tapering sectionof the syringe body. The arm on which the cam 1 c is formed can beelastically deformed relative to the arm on which the engagement element1 b is formed, allowing the cam 1 c to fulfill the intended function interms of the needle protective sleeve 3. In particular, the cam 1 aserves as a stop for the needle protective sleeve 3, whereby the needleprotective sleeve 3 rests against the cam 1 a when the needle protectivesleeve is in its starting position and/or in its needle protectiveposition.

In the fifth embodiment shown in FIGS. 12 a-12 d, the syringe module, inparticular, the syringe holder 1, comprises a sleeve body 103. Thesleeve body 103 comprises in particular, two cams 1 c and, inparticular, two projections 1 a in the manner shown herein.

In this variant, the at least one engagement element can be formedelastically as a shoulder 1 b, in particular, on an elastic arm 1 h onthe syringe holder, whereby the syringe 13 is inserted, through theproximal end with the needle pointing forward, into the syringe holder,which is preferably sleeve-shaped, whereby the needle protective cap 14deflects outward the at least one engagement element 1 b transverse tothe longitudinal axis, i.e., away from the longitudinal axis, causing,if the needle protective cap 14 was moved completely past the at leastone engagement element 1 b, the at least one engagement element 1 b tosnap into the gap between the tapering area of the syringe 13 and theproximal end of the needle protective cap 14. The unit shown in FIG. 12c is then accommodated in the housing 2 of the autoinjector in such away that the holding section 2 b fixes the arm 1 h such that theengagement elements 1 b are held in engagement with the tapering sectionof the syringe body 13 in a force- or form-locking manner and no longerspring out of this engagement.

In FIGS. 8 e, 9 d, 10 e, 11 d, and 12 d longitudinal sections of thefive embodiments in the delivery state are shown, and for theembodiments two to five longitudinal sections are shown after oneassembly step, respectively of the syringe into the autoinjector in oneposition each with a partially and completely inserted syringe. With acompletely inserted syringe, the at least one snap 4 b comprising thepull cap 4 also engages in the gap between the syringe body 13, inparticular, in its tapering area, and the proximal end of the rigidneedle shield 14 (FIG. 2 a, 2 b).

The at least one engagement element 1 b is inserted into the area of theholding section 2 b together with the syringe holder 1 by oneinstallment stroke H_(M), which, in particular, is performed as the lastassembly step, in the axial direction so that a force- or form-lockingconnection results which prevents the at least one engagement element 1b from moving out of engagement with the tapering section of the syringebody 13 transverse to the longitudinal axis, in particular, away fromthe longitudinal axis L or outward. Further, by this installationstroke, the pull cap 4 is moved into its distal position, which itassumes in the delivery state of the autoinjector, whereby the pull cap4 is moved through the syringe holder 1 by means of the at least onesnap hook 4 a which is supported on the syringe holder 1.

1. An autoinjector for dispensing a liquid product, comprising: ahousing; a product container arranged in the housing, the productcontainer comprising a syringe and a displaceable piston for dispensingthe product contained in the product container; a drive member fordisplacing the piston during the product dispensing; a first spring fordisplacing the drive member, wherein the first spring is pretensionedsuch that it can dispense the product from the product container bydisplacing the drive member and the piston by a dispensing stroke in adispensing direction; a signal element; a signal stop; and a secondspring, wherein the second spring exerts a spring force on the signalelement opposite the dispensing direction, and wherein the signalelement is releasably coupled with the drive member in an axial couplingsuch that, during the axial coupling, the signal element is displaced inthe dispensing direction as the drive member is displaced and the secondspring is tensed, and upon release of the axial coupling, the signalelement is displaced by the second spring opposite the dispensingdirection and relative to one or more of the drive member or the housingand strikes the signal stop of the housing thereby generating one ormore of an acoustic or a tactile signal.
 2. The autoinjector accordingto claim 1, wherein the signal element comprises a first engagementelement, which detachably engages the drive member in the axialcoupling, wherein the axial coupling between the drive member and thesignal element is released when the signal element is detached fromengagement with the drive member.
 3. The autoinjector according to claim1, wherein the signal stop is formed axially fixedly connected to thehousing.
 4. The autoinjector according to claim 3, wherein the signalstop is configured as a locking cap for closing a proximal end of thehousing.
 5. The autoinjector according to claim 1, wherein the signalstop is arranged along the longitudinal axis of the housing and inalignment with the signal element.
 6. The autoinjector according toclaim 1, further comprising a needle protective sleeve for acting on thesecond spring and for triggering the product dispensing, wherein theneedle protective sleeve is moveable from its starting position relativeto the housing and along the longitudinal axis of the autoinjector inthe proximal direction by an activation stroke, whereby the secondspring is tensioned and dispensing of the product is triggered.
 7. Theautoinjector according to claim 6, further comprising a switch modulearranged kinematically and/or geometrically between the second springand the needle protective sleeve, wherein the switch module istransported in the proximal direction by the needle protective sleevewhen the needle protective sleeve is displaced from its startingposition in the proximal direction.
 8. The autoinjector according toclaim 7, wherein the signal element comprises: a first engagementelement, which detachably engages the drive member and the signalelement in the axial coupling; and a second engagement element, whichcan be moved into an axially fixed engagement with the needle protectivesleeve or the switch module by a decoupling movement of the axialcoupling between the drive member and the signal element, wherein thefirst engagement element and the second engagement element arecoordinated with one another such that the second engagement elementengages in the axially fixed engagement with the needle protectivesleeve or the switch module when the first engagement element has notyet detached from the engagement with the drive member.
 9. Theautoinjector according to claim 8, wherein the drive member is moveablein the distal direction relative to the signal element by means of thefirst spring when the first engagement element is detached from thedrive member, and the second engagement element is in engagement withthe needle protective sleeve or the switch module.
 10. The autoinjectoraccording to claim 8, wherein the drive member prevents the secondengagement element from moving out of the axially fixed engagement withthe needle protective sleeve or with the switch module when the drivemember moves in the distal direction relative to the signal element,wherein at the end of the dispensing stroke, the drive member allows thesecond engagement element to move out of engagement with the needleprotective sleeve or with the switch module, whereby the signal elementis accelerated by the second spring against the dispensing direction andstrikes the signal stop.
 11. The autoinjector according to claim 7,further comprising a holding element on which one end of the firstspring is supported and which comprises a first engagement element,wherein the first engagement element engages the drive member beforeproduct dispensing is triggered, whereby the drive member is preventedfrom moving in the dispensing direction relative to the holding element,wherein said engagement of the first engagement element can be releasedfor the product dispensing so that the first spring can move the drivemember in the dispensing direction relative to the holding element. 12.The autoinjector according to claim 11, wherein the holding elementcomprises a second engagement element, which can be moved by adisengaging movement of the first engagement element of the holdingelement out of the drive member into an axially fixed engagement withthe needle protective sleeve or the switch module, wherein the firstengagement element of the holding element and the second engagementelement of the holding element are coordinated with one another suchthat the second engagement element of the holding element engages theneedle protective sleeve or the switch module in an axially fixed mannerwhen the first engagement element of the holding element has not yetdecoupled from its engagement in the drive member.
 13. The autoinjectoraccording to claim 12, wherein the drive member prevents the secondengagement element of the holding element from moving out of the axiallyfixed engagement with the needle protective sleeve or with the switchmodule when the drive member moves in the distal direction relative tothe signal element and stops at the end of the dispensing stroke. 14.The autoinjector according to claim 13, wherein the switch modulecomprises a switch sleeve and a blocking sleeve, wherein the blockingsleeve comprises a unidirectionally acting locking element which engagesthe switch sleeve, wherein during its movement relative to the housingin the proximal direction, the switch sleeve transports the blockingsleeve via the locking element, and during its movement relative to thehousing in proximal direction, the blocking sleeve is moved into afurther blocking position in which the locking element blocks a movementof the switch sleeve relative to the blocking sleeve in the proximaldirection.
 15. The autoinjector according to claim 5, wherein upon thedrive member being displaced by the dispensing stroke in the distaldirection, the needle protective sleeve can be moved by the secondspring in the distal direction relative to the housing by a needleprotective stroke into the needle protective position in which theneedle protective sleeve protrudes distally beyond the needle tip of aninjection needle of the product container.
 16. The autoinjectoraccording to claim 15, further comprising a locking element which blocksthe needle protective sleeve in its needle protective position relativeto the housing against being pushed back in the proximal direction suchthat the needle tip cannot protrude from a distal end of the needleprotective sleeve.
 17. An autoinjector for dispensing a liquid product,comprising: a housing; a product container holding the liquid productand arranged in the housing; a drive member for dispensing the liquidproduct from the product container; a first spring for displacing thedrive member in a dispensing direction; a signal element; a signal stop;and a second spring for displacing the signal element opposite thedispensing direction, wherein the signal element is releasably coupledwith the drive member, wherein when coupled to the drive member, thesignal element is displaced in the dispensing direction as the drivemember is displaced and the second spring is tensed, and wherein whenthe drive member is uncoupled from the signal element, the signalelement is displaced by the second spring opposite the dispensingdirection and strikes the signal stop thereby generating a signal.